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Trial Title:
Pain Caregiver Resource (PainCaRe)
NCT ID:
NCT06651190
Condition:
Pediatric Cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Device Feasibility
Masking:
Single (Investigator)
Intervention:
Intervention type:
Other
Intervention name:
Pain Caregiver Resource (PainCaRe)
Description:
The purpose of the PainCaRe mobile health app is to support parents of young children
with cancer (between the ages of 2-11 years) to manage their cancer-related pain at home.
The app will ask caregivers to completed a brief 6-question pain assessment once daily
and complete ad hoc assessments as needed. Based on the results of the pain assessment,
real-time, evidence-based pain management suggestions, including will be provided to
parents. The purpose of the pilot randomized controlled trial (RCT) is to evaluate the
feasibility of implementing PainCaRe in a future RCT. Please find attached the study
protocol for reference.
Arm group label:
Intervention Arm
Summary:
Pain is a problem for children with cancer, especially when they are outside of the
hospital setting. Younger children with cancer are particularly vulnerable to
undermanaged pain because of their inability to self-report pain and their reliance on
parents for treatment. One method to help these children to get the best care possible is
through the use of smartphone-based mHealth solutions. Smartphone apps can provide
treatment advice to patients experiencing pain in real-time and in any environment. This
research will use a phased and user-centered approach with family caregivers to co-design
and co-evaluate the new cancer Pain Caregiver Resource (PainCaRe) app to achieve the
following aims: (1) high-fidelity software development and usability refinement; (2)
evaluation of trial feasibility and preliminary effectiveness in a pilot randomized
controlled trial (RCT); and (3) systematic analysis of caregiver app usage patterns to
refine PainCaRe for optimal engagement prior to a future RCT.
Criteria for eligibility:
Criteria:
1. Be the primary caregiver, or person assuming the majority of care activities, for a
child aged 2-11 years undergoing cancer treatment and experiencing above mild pain
(≥3/10) in the week preceding study enrolment (pain measured by self or caregiver
proxy using a validated numerical 11-point rating scale).
2. Be able to speak and read English.
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The Hospital for Sick Children
Address:
City:
Toronto
Zip:
M5G1X8
Country:
Canada
Contact:
Last name:
The Hospital for Sick Children Research Ethics Board
Phone:
416-813-7654
Phone ext:
205718
Email:
ask.crs@sickkids.ca
Start date:
December 2024
Completion date:
January 2026
Lead sponsor:
Agency:
The Hospital for Sick Children
Agency class:
Other
Source:
The Hospital for Sick Children
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06651190
